A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine (rCM HF-SCS)

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The purpose of this study is to assess short- and long-term safety, tolerability and efficacy of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering from chronic migraine refractory to conventional medical therapy.

During the trial implant of Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine, the 2 leads will be positioned to cover the C2-C3 cervical levels.

Over the following 2 weeks, the investigator will optimize therapy delivery by identifying the stimulation settings providing maximal headache pain relief.

The subject will be asked to attend the clinic at the end of the trial period. Together with his/her physician, the subject will discuss his/her experience over the past 2 weeks (satisfaction with the therapy), and decide whether or not move forward with a Nevro Senza IPG.

The Nevro Senza IPG will be implanted in the buttock or abdomen area as outlined in the Physician's Manual. Fluoroscopy and impedance measurements may be used during the procedure to confirm lead placement and location.

Before hospital discharge, the IPG will be programmed with the optimal settings identified during the trial phase.

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

An adult between the age of 18 and 65

Capable of providing informed consent

A diagnosis of chronic (>15 or more headache-days per 4 week period for more than 3 months, with an headache-day being defined as a day with an attack lasting a minimum of 4 hours) migraine refractory to conventional medical treatment (has failed at least 2 preventive and 2 abortive drugs) as per the ICHD-II guidelines.

Able to comply with the requirements of the study visits and self-assessment questionnaires Able to provide informed consent and willing to comply with study procedures

Exclusion Criteria:

• medication-overuse headache

Had treatment with Onabotulinumtoxin A in the last 3 months

An already implanted active medical device

A contraindication to the cervical placement of SCS lead

A life expectancy of less than 1 year

A female of child bearing potential who is pregnant/lactating or not using adequate birth control

Beck Depression Inventory score of >24

Evidence of an active disruptive psychological/psychiatric disorder or other known condition significant enough to impact perception of pain (e.g. fibromyalgia), compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator

Addiction to any of the following: illicit drugs, alcohol (5 or more drinks/day), and/or medication

Bleeding diathesis such as coagulopathy or thrombocytopenia

Immuno-compromised and at risk for infection

Diabetic which is not under control as determined by the Investigator

Unresolved issue of secondary gain

Inability to manage the technical demands of the SCS equipment

Currently participating in a randomized clinical trial with an active treatment arm or planned to be enrolled in another clinical trial